恆瑞醫藥(600276.SH):氟唑帕利聯合醋酸阿比特龍治療事宜獲臨牀試驗通知書
格隆匯1月13日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。申請事項:氟唑帕利聯合醋酸阿比特龍在轉移性去勢抵抗性前列腺癌(mCRPC)患者中的藥代動力學(PK)和安全性的I期研究。
氟唑帕利是一種聚腺苷二磷酸核糖聚合酶(poly(ADP-ribose)polymerase,PARP)抑制劑,可特異性殺傷BRCA突變的腫瘤細胞,用於治療既往經過二線及以上化療的伴有BRCA1/2致病性或疑似致病性突變的複發性卵巢癌。
經查詢,氟唑帕利目前國外有同類產品奧拉帕利(商品名Lynparza)、盧卡帕利(商品名Rubraca)、尼拉帕利(商品名Zejula)和他拉唑帕利(商品名Talzenna)於美國獲批上市銷售,奧拉帕利片於2018年8月在中國獲批上市,商品名為利普卓。
國內再鼎醫藥的甲苯磺酸尼拉帕利膠囊(商品名:則樂)於2019年12月在中國獲批上市,用於鉑敏感的複發性上皮性卵巢癌、輸卵管癌或原發性腹膜癌成人患者在含鉑化療達到完全緩解或部分緩解後的維持治療。
百濟神州的pamiparib(BGB-290)、人福醫藥的HWH-340等產品處於臨牀試驗階段。經查詢,2018年奧拉帕利(商品名Lynparza)、盧卡帕利(商品名Rubraca)、尼拉帕利(商品名Zejula)和他拉唑帕利(商品名Talzenna)全球銷售額約為6.72億美元,美國銷售額約為3.19億美元。
截至目前,公司在氟唑帕利項目上已投入研發費用約1.99億元人民幣,醋酸阿比特龍項目上已投入研發費用約5214萬元人民幣。
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